CZ20023655A3 - Anatomic two-layer reticulum for surgical purposes - Google Patents

Abstract

A mesh (1) made of monofilament polypropylene (PPL) is disclosed, with surgical quality (CQ) and controlled flat memory (CM), comprising an upper (1') and lower (1") layer joined by welding along almost the entire length of their edges (p) resulting smooth, polished and without ravel; said layers comprise equal coaxial holes (2', 2") for passage of the spermatic cord, two radial slits (3', 3") departing from said holes and forming an angle ( OMEGA ) between 90 DEG and 120 DEG , the zone (q) of the edges between said slits being not joined and free so as to create an upper (5') and a lower (5") fins that can be easily bent. By folding said fins, lowering the upper fin (5') and raising the lower fin (5") respectively, they are firstly opened so as to make easier the subsequent folding and closure by overlapping tucking of the lower fin (5") above the upper fin (5') so as to self block the mesh. Said mesh does not require the suture of the fin openings that in the prior art meshes when not effected causes deformation and misplacement by spreading apart said fins, while when effected causes lack of capability of the mesh to stay flat by bending along the slit, with formation of dead space and serum accumulation, all being primary reasons of relapsing phenomena. The double layer confers ideal stiffness to the mesh however without inpairing the need of accelerated fibroplastic infiltration by the presence of through holes (4', 4"). The mesh finds a particular application in surgical hernia operations, more particularly in hernioplasty with properitoneal (rear) approach with mesh implant.

Description

Anatomical double-layer mesh for surgical purposes

Technical field

BACKGROUND OF THE INVENTION The present invention relates to a two-layer anatomical mesh for surgical purposes, which is intended especially for internal use in the human body and is characterized by an ideal biocompatibility of stiffness and a suitable anatomical shape.

BACKGROUND OF THE INVENTION

The basic problem of surgical treatment of hernia is the possibility of its recurrence and another basic problem is the need to prevent damage to the seminal cord during surgery or its damage or contusion after surgery.

For these reasons, special care should be taken, in addition to the methodology used, to perform a prosthesis for hemioplasty in terms of shape, size and material properties.

The most widespread method in surgical treatment of hernia is the Bassini-Shouldice method, using direct tissue suturing. The introduction of wall-reinforcing prostheses, first of the Marlex-Prolen type and then made of polypropylene, and the subsequent development of their anatomical shape, together with the new surgical techniques introduced today, made it possible to develop new approaches to hernia pathology, either as outpatient surgery without postoperative hospitalization. the proportion of patients undergoing such surgery as soon as the disease is diagnosed, trusting in the speed, simplicity and efficacy of the new techniques, and also made it possible to carry out surgical interventions in patients who have not been able to undergo them in the past because of an overall poor condition.

As mentioned above, the basic problem is to prevent relapses. The reasons for relapses are mainly incorrect positioning of the mesh due to its displacement, deformation or creasing, its sewing and fixation to the wall, causing uneven stress distribution, dead space formation and serum accumulation, hematomas be the cause of mesh displacement, preparation and placement of the seed strand, incorrect shape and size of the mesh, slow or small fibroblastic infiltration. To avoid these causes, prostheses of different surgical quality (CQ) materials and biocompatible mesh shapes with physicochemical and dimensional parameters (elasticity, flexibility, stiffness, wear resistance, thickness, porosity, transparency) are introduced after sterilization. in an autoclave or with ethylene oxide and after implantation, and with a controlled shape memory (CM), i.e. having a shape planar memory that provides crush resistance.

Single-fiber polypropylene (PPL) appears to be the material most appropriate to the above requirements and is therefore preferred by surgeons.

This material has high tensile strength, is biologically stable, excels in good tolerability and does not cause allergic reactions, is not carcinogenic, is resistant to microbial contamination due to its single-stranded character, induces faster fibroplastic proliferation which leads to more efficient deposition of collagen.

These properties can only be obtained by proper mechanical treatment and heat treatment of the material used to make the polypropylene mesh, such as spinning, weaving, prestressing, preheating and other treatments affecting the texture,

2.

fiber diameter, thickness, roughness, pore size, along with a treatment to increase thermal stability, and a final treatment to obtain ideal stiffness and shape memory.

The real drawbacks of this material are thermolability and shape memory in the sterilization of the vautoclave (at a temperature of 126 ° C), which causes deformation of the mesh, considering that the polypropylene has a melting point of about 160 ° C.

A mesh without controlled shape memory tends to crease and the position changes to shift the mesh during or after implantation, creating dead spots, serum secemation and moving the mesh, increasing the risk of relapses.

Thus, it is apparent that the surgical properties that a mesh must have, in particular long-term shape stability, flexibility, durability, ability to adapt to movement and muscle contraction, will primarily depend on the accuracy of processing and treatment of the mesh.

A too soft mesh that initially allows good fit is likely to wrinkle, even during surgery, while a too stiff mesh is difficult to shape, causing subsequent discomfort, incisive or stabbing pain and other reactions in the patient's body.

Industrially preformed prostheses have been switched from shaping, mostly manually in the operating room, to the advantage of a higher guarantee of sterility due to a reduction in the number of handling steps, atraumatic character and durability due to the final machining of edges that are smooth, without sharp sections and seams. Another advantage is the optimal standardization of the shapes, as there are a number of standard sizes available, suitable for different patient pan sizes, which can be tested immediately during surgery.

In order to prevent the relapses caused by the stresses produced by sewing the mesh as an implant prosthesis, new types of sieves and new surgical techniques, such as a non-tufted strain-free mesh, an un-tufted strain-free mesh or an un-tufted mesh for stress-free hemioplasty , Prostheses in abdominal wall hernias (1994) and Trabucco, European Patent Application No. 97 115149 (Publication No. 0827724), corresponding to Italian Utility Model No. 232435.

The technique consists in implanting a pre-formed mesh with a hole and a cut for a seed strand with a standard size selected to optimally and precisely fill the section in a closed anatomical section, for example the inguinal canal. In this case, the mesh, which is prevented from moving within the anatomical section by the fascial and aponeurotic tissue, does not need to be sutured; at the same time, the net is stress-free and does not create dead spaces.

In the mesh sewn to the tissue, unfavorable stress distribution may occur and dead spaces may form; an un-tufted mesh is always free of stress and does not create dead spaces.

An important feature of such a mesh is that it has a well-defined simple standard size (10 x 4.5 cm, hole diameter 1-1.2 cm), because the author, on the basis of extensive observations and anatomical measurements, believes that the dimensions of the inguinal wall it does not differ significantly from patient to patient.

Other manufacturers market the same type of preformed mesh, with or without apertures and recesses, hemial prostheses with a seed strand aperture, identical or similar in shape and nearly identical in size, or in any case close to inguinal gaps, see for example Bard nets, Brown's Premilene or Trelex manufactured by Medox etc.

By this technique, the aponeurosis of the external oblique abdominal muscle is slit longitudinally, the cremaster musculus is divided and longitudinally opened, and then continued to isolate the mesentery of the seminal cord. The keel bag is isolated, introflectured, reduced or surgically treated.

After reconstruction of the bottom of the inguinal canal, a rigid mesh is shaped and dimensionally deformed, which is placed above the fascia transversalis in a closed anatomical section. There is no need to sew the mesh except for closing the holes. Aponeurosis of the external oblique abdominal muscle is finally closed over the seminal string without tension because the lower arm has been enlarged by dissection.

As for the position of the seed strand, it may be either above or below aponeurosis. When the seed strand is in the position below the aponeurosis, the mesh only contacts the fascia transversalis in the medial portion of the inguinal canal; when the seed strand is above aponeurosis, the mesh is in contact with the two layers - underneath the fascia transversalis as well as with the aponeurosis of the external oblique abdominal muscle, thus forming a triple, firmer layer, just where recurrence often occurs.

The seed strand hole or shear may be left free or sewn. However, in the first case, the flaps tend to move away so as to compromise the seal and allow the mesh to move, possibly causing damage to the seed strand. In the latter case, a wedge-shaped bend occurs along the incision, thereby creating dead spaces and conditions for relapse, or possibly damage to the seed strand.

This method is successfully used in hemioplasty of external oblique, inguinal, femoral, inguinal-femoral hernia with inguinal access and frontal repair. However, this method does not solve the problem of deformation and migration of the mesh, either due to the expansion of the loosely retained flaps or due to the folding of the edges sewn at the cut points, preventing the mesh from remaining flat.

In addition, problems associated with the subsequent risk of damage to the seed strand are not solved.

Thus, this type of mesh does not completely eliminate the risks of recurrent hernia.

In order to overcome the drawbacks of the prior art, the present invention relates to a mesh for the surgical repair of low-strength or non-functional tissues, in particular for hemioplasty, which has ideal shape, size, characteristics, stiffness and excels in controlled shape memory.

As noted above, the main cause of relapses is the lability of the flaps formed to cut the seed string mesh, either due to their expansion or bending.

The present invention consists in providing a two-layer mesh consisting of two mutually overlapping layers with identical coaxial openings and radial diverging cuts; the layers are joined along the entire peripheral edge except for the region given by the two cuts to form two flaps that initially overlap, but bend during operation so that the top flap is at the bottom and the bottom at the top, similar to the flaps of the carton when closed.

In this way, as in the above carton example, closure is provided without the need for adhesive tape or metal clips; in the case of a prosthesis according to the invention, the insertion of the flaps ensures the position of the mesh on the seed strand without damaging it and without the need to sew the flaps of said cuts together.

The double layer gives the mesh greater stiffness without compromising its ability to adhere to the tissue, and by using it provides better shape memory control, preventing creasing and displacement of the mesh.

The formation of a slower fibroplastic infiltration caused by the gap between the two layers of the mesh is prevented by the increased uniform macroporosity of the mesh, also given by its thickness when processing the single-stranded mesh, and by creating a number of auxiliary through holes in the mesh with a suitable shape and position.

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Such a mesh can also be implanted using a properitoneal (back) access surgery using laparoscopic techniques.

In particular, the present invention relates to prostheses formed from a bilayer preformed surgical mesh, characterized in that it consists of two layers each having holes of the same diameter joined to a corresponding recess, the mesh overlapping so that said holes are aligned coaxially above while said recesses are arranged in divergent lines enclosing a preselected angle.

Some specific embodiments of the invention will now be described in the following paragraphs.

The prosthesis according to the invention is characterized in that the overlapping top and bottom layers are joined along their outer edge, with the exception of the area between two recesses or longitudinal openings, to form the corresponding top and bottom flaps, thereby securing the mesh itself positively.

A further characteristic of the mesh is that the longitudinal openings connecting the openings in each layer to the respective outer edge are radially cut in each diverging direction in a diverging direction so as to form an angle between 90 and 120 °.

In the mesh according to the invention, the two layers are joined along their contour lines, with the exception of the flap portion, by means of a laser weld, thereby obtaining completely smooth, burr-free and sharp edges.

In another particular embodiment, the two layers are welded not only along the respective edges, but also over the entire area of their contact except the flap sections.

Such a modified embodiment makes it possible to produce large prostheses, which can then be dissected by the surgeon during surgery to obtain a mesh perfectly adapted to the patient and meeting specific needs.

The mesh according to the invention is made of surgical quality (CQ) single stranded polypropylene (PPL), with controlled shape memory (CM) and with optimal resistance, flexibility, roughness and stiffness.

The surgical quality (CQ) of the mesh means that the mesh meets the criteria of biocompatibility and thermal stability, and has a high degree of macroporosity, which is responsible for rapid fibroplastic infiltration.

The macroporosity of the mesh described is due both to manufacturing treatment and to the presence of additional openings through the double layer. These openings are optimally designed for shape, size, diameter, number and uniformity with respect to the thickness of the bilayer mesh in order to counteract the retardation of fibroplastic infiltration due to the gap between the two layers and to accelerate the infiltration while maintaining optimum stiffness.

Controlled shape memory represents the ability of the mesh to maintain its shape without the tendency to wrinkle while maintaining the ability to adhere perfectly to the tissue. It is best to use a mesh with controlled planar memory.

The present invention also relates to the use of the disclosed mesh in the surgical treatment of hernia, particularly in properitoneal (posterior) hernioplasty, also of laparoscopic or open type, with mesh implantation.

BRIEF DESCRIPTION OF THE DRAWINGS

A description of a typical example of the use of the mesh according to the invention is given below with reference to the figures in the attached set of drawings; however, this does not limit the general scope of the invention.

• · ·· ΦΦ

Giant. 1 is a top view of a mesh according to the invention;

FIG. 2 is a side sectional view of a mesh;

FIG. 3 is a perspective view of a herniotic prosthesis; the mesh is inverted to show better movement of the flaps (lower flap is raised, upper flap is down) and retracted after bending the flaps in the opposite direction to that shown; FIG. 4 is a top view of the prosthesis of the invention with through holes to promote fibroplastic infiltration;

FIG. 5 is a top view of a prosthesis showing the parameters defining its characteristic size;

Fig. 6 - Placement of a prosthesis around a seed strand.

DETAILED DESCRIPTION OF THE INVENTION

The mesh 1, made of surgical quality (CQ) single-stranded polypropylene (PPL), with controlled shape memory (CM), consists of an upper I 'and a lower 1 layer welded along almost the entire edge length ps with the exception of the qa portion corresponding to the flap 5' and 5, which are smooth, shiny and burr-free as seen in Fig. 1a. In these layers, identical coaxial holes 2 'and 2 are identical, of which two radial recesses or cuts 3' and 3 lead at an angle jehož, the size lies between 90 and 180 °. The region of the edge q between said recesses is not joined but is cut to form upper and lower flaps 5 ' and 5 that can be easily bent as shown in FIGS. 1, 2 and 3.

By bending said flaps, i.e. lowering the upper flap and raising the lower flap, the flaps are first opened to facilitate subsequent bending and closing by sliding the lower flap above the upper; this procedure is shown in Fig. 3 and for clarity the mesh 1 is rotated.

In this way, perfect dimensional stability of the mesh prosthesis is achieved during the surgical procedure, without undesirable deformations, while maintaining the required elasticity, flexibility and fit; the mesh 1 retains the ideal rigidity and controlled shape memory.

A preferred particular embodiment has an anatomical shape with the following characteristic dimensions relative to the xx 'and yy' axes: length 1 = 12 cm, height j = 8 cm, horizontal distance from aperture a = 7 cm, b = 4 cm; horizontal distance from hole center f = 7.5 cm, g = 4.5 cm, vertical distance from hole h = 4 cm, k = 3 cm, hole diameter Φ = 1 cm, flap angle Ω = 90 °, flap angle relative to the vertical axis yy 'a = β = 45 °, the distance of the start of the fillet from the horizontal edges r = s = 2 cm, the vertical distance between the start of the vertical fillet t = 4 cm - see Figure 5.

The second preferred particular embodiment has an anatomical shape with the following characteristic dimensions: 1 = 11 cm, j = 7 cm, Φ = 1 cm, with the same angles and proportional reduction of all other dimensions according to Fig. 5.

Since sewing, which is the primary cause of relapses due to the loss of the ability of the aforementioned types of netting to maintain a planar shape, is unnecessary for this type of netting, there is no bending of the net, dead space formation and serum accumulation. In addition, the self-locking mesh allows for perfect sewing operations without stitching and tension; stress is another primary factor in relapses.

The double layer allows to achieve higher stiffness, which is advantageous because the softer mesh is easier to wrinkle and move, but it causes slower fibroplastic infiltration due to the gap or dead space between the two layers and thus is less resistant to infection. This disadvantage is counterbalanced by the macroporous mesh and the presence of additional holes having a uniform shape, size, diameter, number and arrangement according to the thickness of the mesh, which makes the mesh infiltrating ability of the invention possible or even higher.

A variant of this mesh is provided with openings 4 ', 4 passing through a double layer as in a colander, in order to increase fibroplastic infiltration and collagen deposition to prevent infections and postoperative complications and achieve faster healing of the patient (Figs. 2 and 4).

Generally, the additional holes have a diameter of 1 mm and are preferably between 6 and 10, see Figures 2 and 4.

Heritoplasty with properitoneal approach and mesh implantation will be described in the following section.

PATIENTS AND METHODS

Table 1, below, summarizes the incidence of complications and relapses in various methods of operative hernia treatment.

Table 1

Authors Technique Complication Relapse hernia repair with stitching, without prosthesis Hay, 1995 Bassini 27% 8.6% Emmanoulidis, 1993 Hay, 1995 Kingsnorth, 1992 Shouldice 19% 3% prosthetic frontal approach Wantz, 1966 Liechtenstein 12% 0.5% Campanelli, 1993 Trabucco 12% 1.5% prosthetic properitoneal approach Stopp, 1989 Stoppa 3.5% 1.1% Topla, 1997 Rignault, 1986 Rignault 2% 2%

Personal experience results from a group of 2670 selected and operated patients with pathological inguinal hernia. The operations were mostly performed in the operating theaters of the Surgical Department of the Hospital and University Hospital of Naples, where they were performed exclusively by authors over several years using the various techniques listed in Table 2.

Table 2

Techniques used in hernioraphia

Period Technique Number of patients 1976- 1981 Bassini 315 1982- 1988 Shouldice 1007 1989- 1993 Trabucco 639 1994- 1999 properitoneal mesh 709

In the present summary, only adult patients (388) operated for a period of three years (1994-1996) are taken into account as they are a sufficiently homogeneous group that has undergone a follow-up program that ended last year; 86% of the patients (344) were examined in four scheduled examinations and 100% in at least three of the planned four examinations.

From January 1994 to December 1996, 388 adult patients, of whom 372 men (96%) and 16 women (4%), with an average age of 62.7 years (range 22-88), underwent surgery, hemioplasty, with application nets by properitoneal route.

Of these patients, 216 (56%) had an indirect hernia, 94 (24%) had a direct hernia and 78 (20%) had both (indirect and direct) hernia. Eighty-five patients (22%) suffered from multiple hernias (85% bilateral hernia and 7% (27 patients) had homolateral inguinal and femoral multiple hernia). None of the patients suffered from femoral-type hernia alone. 31 cases (8%) experienced a recurrent inguinal or femoral hernia.

The prostheses used are in the manufacture of different sizes according to the type of the patient's pelvis. The nets were made according to our specification (shape, thickness and texture), based on surgical experience from performed surgeries. The choice of the preformed polypropylene mesh used was dictated by the advantages of sterility (easier handling), atraumatic character, resistance (welded edges of the mesh), and the standardization of the shape that this type of product makes compared to the mesh, manually, with considerable time loss auditorium.

Surgery was performed by transversal incision about 2.5 - 5 cm below the anterior upper thorn (spina illiaca anterior superior) with an average length of 5-6 cm. After shunting the abdominal lateral muscles, the opening of the peritoneal cavity continued, securing the iliac vessels, the anulus femoralis and the anulus inguinalis. The hernia sac was then reduced, and of course other manifestations associated with various direct or femoral hernias, and isolated by retractable maneuvers from the cord and properitoneal adipose tissue of the posterior canal wall toward the genital tuberculum; particular attention should be paid to the numerous small inflammatory liposomes present on the femoral anulus, usually sessile to the iliac veins, which must be carefully removed as they play a not insignificant role in relapsing.

At this point, a suitable prosthesis size is selected, a vertical pruning of 2-3 cm at the upper edge through which the seed strand passes, and then the prosthesis is placed so as to cover the entire inner surface of the posterior inguinal wall with a small iliac vessels in the juxtafemoral position.

The ideal shape and size of the prosthetic mesh is the subject of extensive discussion, but our experience supports the selected size, shape, thickness and quality of the polypropylene mesh used by us. It turns out that the mesh chosen by us optimizes the technique used in terms of surgical procedure and results.

In our opinion, the cornerstone of adherence to the basic principles of surgery: good haemostasis, accurate anatomical structure preparation, and correct positional application of the mesh, with careful monitoring to avoid its creasing and the mesh is laid in a perfect plane, without folds or wrinkles.

We have tried to pay special attention to haemostasis, because hematomas are one of the causes of relapses, because they can change the position of the mesh. Wantz recommended the use of drainage in cases where the bleeding was imperfect or where blood was accumulating in a large bag. We never used drainage.

In 39 patients (10%) general anesthesia was used, mostly at their own request. Local local anesthesia (330 with spinal infiltration and 19 with local infiltration) was performed in 349 patients (90%). In any case, the type of anesthesia had no relation to relapses.

The duration of surgery was on average 40 minutes (range 30 - 70 minutes). On request, patients underwent post-operative analgesic therapy with Ketorolac (30 mg i.m.) for 4-6 hours after surgery and were discharged on the first day in 384 cases (98%).

Claims (14)

Anatomical two-layer mesh made of a two-layer preformed surgical mesh (1), characterized in that it consists of a top layer (T) of a mesh and a bottom layer (1 ") of a mesh, each of which has holes (2 ', 2). with the same diameter associated with corresponding recesses (3 ', 3), said layers (Γ, 1) overlap each other so that said openings (2', 2 ”) concentrically coincide while said recesses (3 ', 3) are mounted in diverging lines with a predetermined angle (Ω) (Figs. 1 and 2). Anatomical double-layered mesh according to claim 1, characterized in that said upper (T) and lower (Γ ') overlapping layers are joined along their outer edges (p) ^{with the} exception of the part (q) between two recesses or punchings which form two corresponding loose flaps (upper and lower, 5 'and 5'), wherein the lower flap (5) is bent up and the upper flap (5 ') is bent down so that the lower flap is slid under the upper flap and overlaps with it the position of the mesh itself ensures. Anatomical double-layered mesh according to any one of claims 1 or 2, characterized in that the recess (3 ', 3 ") connecting the openings (2', 2) of each layer (Γ, 1") to the respective outer edge (p, q) ), are punched into each layer in the direction of radial divergent lines forming an angle (Ω) of between 90 ° and 120 °. Anatomical double-layered mesh according to any one of claims 1 or 2, characterized in that in the recesses (3 ', 3 ") connecting the openings (2', 2") of each layer (Γ, 1) to the respective outer edge (p, q). ), are punched into each layer in the direction of radial divergent lines forming an angle (Ω) of between 90 ° and 180 °. Anatomical double-layered mesh according to any one of claims 1 or 2, characterized in that the recess (3 ', 3 ") connecting the openings (2', 2") of each layer (V, 1) to the respective outer edge (p, q). ) are punched into each layer in the direction of radial divergent lines forming an angle (Ω) of 180 °. Anatomical double-layered mesh according to any one of claims 1 to 4, characterized in that it has an anatomical shape with the following characteristic dimensions with respect to the axes (xx '), (yy'): length (1) = 12 cm, height (j) = 8 cm, horizontal distance from hole (a) = 7 cm, (b) = 4 cm; horizontal distance from hole center (f) = 7.5 cm, (g) = 4.5 cm, vertical distance from hole (h) = 4 cm, (k) = 3 cm, hole diameter (Φ) = 1 cm, flap angle (Ω) = 90 °, flap angle to yy 'vertical axis α = β = 45 °, initial fillet distance from vertical side edge (c) = (d) = 4 cm, fillet start distance from horizontal edges r = s = 2 cm, vertical distance between the start of vertical fillets t = 4 cm (see Figure 5). Anatomical double-layered mesh according to any one of claims 1 to 4, characterized in that it has an anatomical shape with the following characteristic dimensions with respect to the axes (xx '), (yy'): 1 = 11 cm, j = 7 cm, Φ = 1 cm, with the same angle values and relatively reduced in all other dimensions (see Fig. 5). Anatomical double-layer mesh according to any one of claims 1 to 7, characterized in that the two layers are joined along their perimeters (p) with the exception of the part (q) corresponding to the flaps (3 ', 3 ") by laser welding to obtain a shiny , completely smooth edges, without sharp spots and burrs. Anatomical double-layered mesh according to claim 8, characterized in that the two layers are welded in addition to the length of the corresponding edges (p) also over the entire contact surface, with the exception of the areas corresponding to the flaps (3 ', 3). Anatomical double-layer mesh according to any one of claims 1 to 9, characterized in that it is made of surgical grade (CQ) polypropylene (PPL) and controlled shape memory (CM), with ideal resistance, elasticity, coarseness and stiffness. Anatomical double-layer mesh according to claim 10, characterized in that said mesh is available for use with a controlled planar shape memory. Anatomical double-layer mesh according to any one of claims 1 to 11, characterized in that it is macroporous as a result of manufacturing processing and comprises additional openings (4 ', 4 ") passing through the double layer (Γ, 1) with optimum shape, size, number and uniform arrangement in relation to the thickness of said double layer to balance and increase fibroplastic infiltration, retarded by the gap between the two layers, while maintaining ideal stiffness (Figs. 2, 4). Anatomical double-layered mesh according to claim 12, characterized in that said openings have a diameter of 1 mm and preferably have a number of between 6 and 10. Use of the anatomical two-layer mesh according to any one of claims 1 to 13 in the surgical treatment of hernia, in particular in hemioplasty with properitoneal (posterior) access, even laparoscopic or open, with a mesh implant.